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临床试验/NCT04748835
NCT04748835已完成不适用

Investigating Factors Related to Nutritional Intake and Weight Gain Among Those With SCI Over the First 12 Months Following Discharge From Inpatient Rehabilitation

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Change in nutritional intake

研究概览

简要总结

People with SCI are at higher risk of obesity and chronic diseases, such as hypertension, high cholesterol, diabetes and cardiovascular disease, than the general population. Researchers currently lack data on factors that influence weight gain among people with SCI. During this one-year observational study, study staff will enroll 60 individuals with SCI while they are inpatients at Baylor Scott & White Institute for Rehabilitation (BSWIR). Data will be collected at 3 time periods (before discharge and 6 and 12 months after discharge) in order to better understand factors that affect weight gain over the first 12 months following discharge from inpatient rehabilitation, such as nutritional intake, environmental access, psychosocial factors, energy requirements and risk factors for metabolic syndrome. These data will be used to inform future interventions for people with SCI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ≥18 years with complete or incomplete spinal cord injury (SCI)
  • Currently have or are expected to regain enough arm function within 6 months to feed themselves independently.
  • Injury occurred within previous 18 months

排除标准

  • Unwilling or unable to complete repeat assessments
  • Cognitive impairment or brain injury that limits ability to provide data

结局指标

主要结局

Change in nutritional intake

时间窗: 1 year

Measure self-report and hospital reported average daily caloric intake, macronutrients (protein, fats, carbohydrates), and micronutrient (sodium) over 3 days at each study time point: baseline, 6 months, and 1 year

Changes in environmental access to kitchen appliances and self-reported limitations and assistance needed for selecting, preparing, and eating meals.

时间窗: 1 year

Using the Assessment of life habits survey (abbreviated as LIFE-H) to determine the proportion of individuals with SCI who require assistance using kitchen appliances and preparing meals. Additional qualitative analyses will include examining the digital photos for intra-individual variation across time to determine whether there are changes to improve access to kitchen spaces and appliances.

Correlation between psychosocial factors (mood, stress, coping, and sleep) and caloric intake

时间窗: 1 year

Mood will be measured using the Positive and Negative Affect States Scale (PANAS); stress will be measured using the Perceived Stress Scale (PSS-4); coping will be measuring using the Daily Coping Inventory (DCI); sleep will be measured with the Pittsburgh Sleep Quality Index (PSQI). Caloric intake is measured through participant self-report through the HealthWatch 360 app, the Automated Self-Administered Recall System (ASA-24) or through hospital records.

Changes in resting metabolic rate

时间窗: 1 year

As measured by resting metabolic rate using a MedGem device

Time spent performing physical activity

时间窗: 1 year

Time spent performing physical activity at each of the study timepoints will be measured using an Actigraph device

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Katherine Froehlich-Grobe

Director of Rehabilitation Research

Baylor Research Institute

研究点 (1)

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